Nicotine and Caffeine Pouches for Fatigue

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of Southern Mississippi

Must not be taking: Insulin, Supplements, Nicotine, Caffeine

Disqualifiers: Diabetes, Heart disease, Hypertension, others

Compensation: Varies

Number of Visits: 4

Duration: 4 separate occasions

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized placebo controlled crossover trial is to determine effects of oral nicotine and caffeine pouches on anaerobic performance, autonomic function, cognition, and behavior in adult non-obese adult male volunteers between ages 21 and 40. Accordingly, the primary aims of the study are to determine the effects of acute oral nicotine pouches, oral caffeine pouches, or both, on measures of * anaerobic performance * cognition * cardiovascular and autonomic function * appetite and food intake. Researchers will compare oral nicotine pouches, oral caffeine pouches, both oral nicotine and caffeine pouches, and a flavor and color matched placebo to see if how they differentially affect measurements of * physical performance, * cognition, * cardiovascular and autonomic function * appetite and food intake. On four separate occasions, participants will be asked to place the oral pouches in their mouth and complete several anerobic cycling, cognitive, and balance tests while blood and salivary biomarkers, subjective appetite ratings, and cardiovascular and autonomic function measurements are collected. After each trial, participants will complete a 24-hr food record.

Research Team

Austin J Graybeal, PhD

Principal Investigator

University of Southern Mississippi

Eligibility Criteria

This trial is for non-obese adult males aged 21-40 who want to participate in a study evaluating the effects of nicotine and caffeine pouches on physical performance, brain function, heart health, and appetite. Participants must be willing to use oral pouches and complete various tests.

Inclusion Criteria

Having a body mass index (BMI) of less than 30 kilograms/meter-squared

Participating in moderate/vigorous exercise for at least 150 minutes/week over the last month

I am between 21 and 40 years old.

Exclusion Criteria

I am missing a limb or part of a limb.

I take insulin injections.

I am not taking supplements or medications that could affect the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral nicotine and caffeine pouches or placebo and complete anaerobic cycling, cognitive, and balance tests

4 separate occasions

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 hours post each visit

Treatment Details

Interventions

• Oral Pouch - Caffeine
• Oral Pouch - Nicotine
• Oral Pouch - Placebo

Trial Overview The study is testing how oral nicotine pouches, caffeine pouches, both combined, or placebo affect anaerobic performance (like cycling speed), cognition (thinking skills), cardiovascular/autonomic function (how the heart works), and food intake.

Participant Groups

Group I: Oral Nicotine Pouches Experimental Treatment 1 Intervention

Single dose 3mg oral nicotine pouch

Group II: Oral Caffeine Pouches Experimental Treatment 1 Intervention

Single dose 100mg oral caffeine pouch

Group III: Combination of oral nicotine and caffeine pouches Experimental Treatment 2 Interventions

Single simultaneous doses of a 3mg oral nicotine pouch and a 100mg oral caffeine pouch

Group IV: Placebo Placebo Group 1 Intervention

Flavor, color, and appearance matched placebo

Who Is Running the Clinical Trial?

University of Southern Mississippi

Lead Sponsor

Trials

16

Recruited

3,200+